A Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer.

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New York,
New York10065

Purpose:

The purpose of this study is to see how well patients tolerate the side effects of treatment
with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used
together are a useful way of treating cancer. We have studied these drugs and know the best
doses of each when they are used alone. We do not yet know how well the drugs work with each
other. This study will tell us the best doses of each drug when they are given over the same
period of time.

Criteria:

Inclusion Criteria:
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver
with no clinical or radiographic evidence of extrahepatic disease.
Confirmation of diagnosis must be performed at MSKCC.
- Patient's liver metastases must be deemed unresectable and comprise <70% of the liver
parenchyma.
- A patient may have had prior chemotherapy or be previously untreated.
- Patient may not have received prior treatment with FUDR or >2 doses of Oxaliplatin.
- KPS > or = to 60%.
- WBC > or = to 3,000 cells/mm3 and platelet count > or = to 100,000 cells/mm3 within 14
days of registration.
- Creatinine < or = to 1.5 mg/dl within 14 days of registration.
- Total serum bilirubin < or = 2.0 mg/dl within 14 days of registration.
Exclusion Criteria:
- No active concurrent malignancies: except a patient's potentially resectable
colorectal primary.
- Patient must not have obstruction of GI or GU tract.
- Patient must not have current, symptomatic peripheral sensory neuropathy.
- No prior radiation to liver.
- No active infection, ascites, or hepatic encephalopathy.
- Age ≥ 18 years.
- Female patients cannot be pregnant or lactating.
- Signed informed consent.